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This study is a single arm study to access the anti-tumor efficacy and safety of sunvozertinib in untreated advanced NSCLC patients with EGFR uncommon mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunvozertinib 300mg | Experimental | sunvozertinib monotherapy, 300mg QD |
|
| sunvozertinib 200mg | Experimental | sunvozertinib monotherapy, 200mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunvozertinib 300mg | Drug | sunvozertinib monotherapy, 300mg QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | from first dose to last dose ,up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | from first dose to first documented disease progression assessed by investigator or death due to any cause up to 48 months ,up to 18 months | |
| Duration of Response (DoR) | for subject with PR or CR defined as the time from the first dose documentd CR or PR to disease progression or death up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jialei Wang | Contact | 18017312369 | wangjialei@shca.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan university shanghai cancer center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| sunvozertinib 200mg |
| Drug |
sunvozertinib monotherapy, 200mg QD |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |